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The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

Devicemaker Admits it Failed to Report Wound Dressing Recall

A Maryland-based device manufacturer pleaded guilty to a single misdemeanor count of failing and refusing to report removal of their MicroMatrix powder wound dressing product — and will pay $15 million to settle the matter.

The Department of Justice said ACell failed comply with the FDA’s postmarket compliance requirements when it neglected to alert the agency about the recall, putting patients at risk. The company has agreed to enter into a five-year agreement that requires implementation of a risk assessment and an internal review process.

“By not notifying the FDA nor being forthcoming about their reasons for the product removal, ACell executives placed profit above patient safety,” said Acting FDA Commissioner Ned Sharpless. “They risked that doctors would use the devices in procedures that could jeopardize patient health.”